SENior PRIorat: Participatory Research for the Improvement of Lifestyles, Quality of Life, Emotional Well-being, and Locomotor Abilities of Older Adults in the Priorat

NCT07189533 | Not Yet Recruiting

• 2 other identifiers: 010/2025FCT-24-19957
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Spain is experiencing a demographic shift towards an ageing population. In 2022, 20.1% of Spaniards were 65 or older, a figure projected to reach 30.4% by 2050. The trend is especially marked in rural areas, where outmigration of younger generations has left a high concentration of older residents. In Catalonia's Priorat county, the share of people aged 65+ already exceeds 20%, reaching 30%, and even 40% in some villages. The ageing process brings biological changes that reduce locomotor and cognitive abilities, limiting autonomy and quality of life. In rural areas, these challenges are compounded by social isolation and the lack of support networks, making older adults more vulnerable. Healthy lifestyle habits-such as balanced nutrition, regular exercise, avoiding tobacco and alcohol, and good sleep-can help delay dependence, lower the risk of chronic disease, and improve well-being. To promote these habits, social innovation must generate new services and approaches that address real needs, barriers, and motivations in adopting healthier lifestyles. Our group's research shows that participatory science is an effective tool to promote healthy ageing in rural settings. A three-month intervention co-designed with older adults in villages of ≤2,000 inhabitants led to improvements in locomotor function, measured through sarcopenia parameters, and enhanced quality of life in areas such as vitality, mental health, and social functioning. A distinctive feature of this approach is shared decision-making between residents and policymakers, ensuring that solutions are adapted to local realities. This fosters greater adherence, empowerment, and long-term sustainability of co-created strategies. This project is directly relevant to public policy through collaboration with the Consell Comarcal del Priorat, which represents 23 municipalities. Their recent report identified ageing as a major concern for both institutions and residents. The project's results can therefore guide health policies-decisions, plans, and actions-that address local needs while considering available resources and ensuring long-term sustainability. By focusing on health promotion and disease prevention, the project ensures that policies are evidence-based and subject to evaluation. The partnership with the Consell Comarcal also aligns with Sustainable Development Goal 3 (Health and Well-being) of the 2030 WHO Agenda and supports the "Health in All Policies" approach, fostering integrated strategies across sectors. The principal aim of the study is to evaluate the effectiveness of a participatory science intervention study in improving lifestyle habits (dietary habits, physical activity, substance use, and sleep quality), quality of life, emotional well-being, and locomotor capacities through the assessment of sarcopenia parameters (muscle strength, muscle mass, and physical function) in young-old adults (≥60 years) living in rural areas of the Priorat region (Catalonia, Spain). Specific Objectives:

1. 1.To describe the health status of older people residing in the Priorat region by evaluating: lifestyle habits (diet, substance use, physical activity, and sleep), risk of malnutrition, functional capacity based on sarcopenia parameters, mental capacity (mental health and emotional well-being), and quality of life.
2. 2.To improve lifestyle habits (diet, physical activity, sedentary behaviour, sleep habits, and substance use-alcohol and smoking), emotional well-being and personal relationships to avoid unwanted loneliness, quality of life, and locomotor abilities based on sarcopenia parameters (muscle strength, muscle mass, and physical function).
3. 3.To reduce the risk of malnutrition.
4. 4.To compare the health status of two groups: those aged 60-74 (young-old adults) and those aged 75 and over (older people).
5. 5.To identify the needs, barriers, and motivations of older people through focus groups, including participants aged 60-74, those over 75, and stakeholders such as members of the public administration supporting the project.
6. 6.To compare the differences in needs, barriers, and motivations identified by the young-old adults (60-74 years) and the older people (≥75 years).
7. 7.To actively involve older participants in the co-creation of health promotion activities and an intervention designed for them and their peers.
8. 8.To implement an intervention based on proposals generated during the co-creation process to improve their lifestyle (dietary habits, physical activity, substance use, well-being, and sleep behaviours), quality of life, and locomotor abilities.
9. 9.To analyse environmental barriers, using the "Age-Friendly Cities and Communities Questionnaire (AFCCQ)", in the villages of the Priorat region that may influence the ability to maintain a healthy lifestyle and quality of life for people aged 60-74 and those aged 75 and over.

Conditions

Healthy Lifestyle

Keywords

Participatory research; healthy lifestyle; quality of life; older adults; rural environment

Outcome Measures

Primary Outcomes (9)

• Nutritional intake

  The Food Frequency Consumption Questionnaire (FFCQ) (Rodríguez IT, et al. Nutr Hosp. 2008) to assess the nutritional intake of elderly participants.

  Baseline and follow-up (6 months later)

• Physical activity and sedentary behaviour

  International physical activity questionnaire for elderly: IPAQ for elderly IPAQ-E, Spanish version (Rubio-Castañeda et al., 2017). Higher scores mean a better outcome.

  Baseline and follow-up (6 months later)

• Sleep quality

  Pittsburgh questionnaire (Buysse et al., 1989). The maximum score is 21 points. More than 5 points are considered bad outcomes and sleep problems, and less than 5 points are considered better outcomes and no sleep problems.

  Baseline and follow-up (6 months later)

• Depressive symptoms

  Geriatric Depression Scale Questionnaire (Yesavage et al., 1983). The maximum punctuation is 15. The score is 0-4, no depression; 5-8, mild depression; 9-11, moderate depression; and 12-15, severe depression.

  Baseline and follow-up (6 months later)

• Quality of life behaviours

  Quality of life assessed by the SF-36 Health survey questionnaire (Ware \& Sherbourne, 1992) and the EuroQol-5D questionnaire (Herdman M et al., 2001). Higher scores mean a better outcome.

  Baseline and follow-up (6 months later)

• Muscle strength

  The muscle strength assessed by handgrip dynamometry (Jamar dynamometer; Sammons Preston Rolyan, Bolingbrook, IL).

  Baseline and follow-up (6 months later)

• Muscle mass

  Muscle mass (appendicular skeletal muscle mass (kg)) assessed by Bioimpedance TANITA (MC-780MA; Tanita Corp., Tokyo, Japan).

  Baseline and follow-up (6 months later)

• Physical performance

  Gait speed (m/s) assessed by the length of the walking course divided by the time (Ladang et al., 2023).

  Baseline and follow-up (6 months later)

• Nutritional status

  Hemoglobin (g/dl) in blood samples assessed by HemoCue® Hb 801 (HemoCue AB, Ängelholm, Suecia, 2020).

  Baseline and follow-up (6 months later)

Secondary Outcomes (20)

• Nutritional status

  Baseline and follow-up (6 months later)

• Anthropometric measures

  Baseline and follow-up (6 months later)

• Anthropometric measures

  Baseline and follow-up (6 months later)

• Anthropometric measures

  Baseline and follow-up (6 months later)

• Anthropometric measures

  Baseline and follow-up (6 months later)

Study Arms (2)

Intervention

EXPERIMENTAL

Receive the co-created intervention

Behavioral: Co-created intervention

Control

NO INTERVENTION

still with their habitual lifestyle

Interventions

Co-created intervention BEHAVIORAL

Intervention generated by a participatory research process (co-creation) in the elderly population living in rural areas to co-create solutions to improve their lifestyles, quality of life and health.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 60 years or older
• Signed informed consent
• Living independently
• Capacity to follow and complete the study
• Resident in one of the villages of the Priorat region

Sponsors & Collaborators

• University Rovira i Virgili: lead
• Consell Comarcal del Priorat: collaborator
• Fundación Española para la ciencia y la tecnologia: collaborator

Study Sites (1)

Universitat Rovira i Virgili

Reus, Tarragona, 43201, Spain

Location

Central Study Contacts

Elisabet Llauradó, PhD

CONTACT

+34977759375; elisabet.llaurado@urv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The allocation will not be blinded due to the nature of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Lecturer

Model Details: Intervention group: receive the co-created intervention Control group: still with habitual lifestyle.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)